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Have you ever thought about how a medical device manufacturer would vet a business opportunity?

Vetting a business opportunity is a critical first step in building a relationship between an OEM and a Supplier.

In the October issue of MPO, a feature article written by Jim Stommen entitled "Let the Vetting Begin"offers insight to the early interactions of an OEM and a supplier as they both evaluate the business partnering relationship. This topic was also discussed recently at the 4th Annual MPO Symposium during the "Building the Bridge Between OEM Design and Outsourced Manufacturing" panel session.

"When evaluating a large OEM business opportunity we look at the types of products in their portfolio, the competition in their industry, their product sales/distribution channel, and the alignment of our quality system to theirs. For a start-up company, having confidence with the management team and their technical, financial and schedule objectives is an essential foundation for a successful business partnering relationship. " stated Jellison.

Successful medical device design follows a proven process that complies with the applicable regulatory standards. ISO 13485 requires that a comprehensive management system be established and maintained to monitor and control/mitigate risks from product inception through design transfer and into production, referred to by the FDA as Total Product Life Cycle (TPLC). There are various stage gate reviews during the TPLC with the Manufacturing Readiness Review being the final gate for the design transfer to production.

By the time a medical device design is ready to transfer to a medical manufacturing/production environment, many if not all of the identified risks should have been eliminated or mitigated (i.e. by design, process control, labeling). The design history file is complete with supportive verification testing data and the documentation to procure, fabricate, tool, build, and test has been released in support of a production lot build. But ... are you ready ?

A manufacturing readiness review is a key tool of a proven process that provides the insight to determine whether the output of the design process coupled with the manufacturing, supply chain, and quality team preparedness meet all the requirements to move to a production manufacturing environment.

Moving through this gate without completing all the elements could cause costly engineering changes, rework and product recalls in the future. Moving too slowly through this gate could cause product launch delays and potentional erosion of market share. This is why a well planned and executed medical product development process with meaningful medical product design stage gates/reviews which culminate in a manufacturing readiness review will lead to a smooth transfer from medical device design to production.